Associate II-BTx PS ARD Reg Support

4 weeks ago

Chennai, India Pfizer Full time

The qualified candidate will join the Analytical R&D support team under GRS and contribute to the development of biological therapeutic candidates through innovation and delivery of cutting-edge analytical science. The qualified candidate will primarily perform activities pertaining to the review and approval of validation related documents as a part of an organization that focuses on method validation and transfer of analytical methods and technologies for biological therapeutics. The group is responsible for the validation and late-stage analytical lifecycle management of quality-controlled methods as they are established in commercial manufacturing sites. Qualified candidates will deliver results in a fast-paced matrix-oriented setting and be a contributor to method validations and transfers. The role is in support of products and process development for biotherapeutics and vaccines, including antibodies, antibody-drug conjugates, and therapeutic proteins, in late-stage clinical development.

Functions at an individual contributor level to support Pfizer portfolio for the ARD business of Pfizer Biotherapeutics PharmSci.

Candidate should have a good foundation of laboratory operations and scientific principles. They will be involved in the content review of and verification of data for validation reports, and related documents. The candidate is expected to gain a systematic understanding of analytical methods including HPLC, CGE, iCE, PCR, ELISA, and other relevant assays applied to the QC testing of biotherapeutics and vaccines. The colleague must be able to interact effectively with peers and leaders as part of a multi-disciplinary team. The candidate must thrive in a fast-paced matrixed environment. Attention to detail, strong organizational skills, the ability to multitask and effective interpersonal and communication skills are required. Documentation of analytical results in regulated systems is required. 

QUALIFICATIONS / SKILLS

Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.

Preferred Education:

Bachelors degree in analytical chemistry, biochemistry, biology immunology, molecular biology, or related field is required with laboratory experience (preferably GMP) or

Masters degree in analytical chemistry, biochemistry, biology immunology, molecular biology or related field

Preferred Experience:

Minimum of 1-4 years of experience in an analytical laboratory experience in a variety of laboratory techniques is required.

Working knowledge of interpreting analytical outcomes such a reading a chromatogram is highly desirable.

Prior exposure (directly or indirectly) to regulatory documentation such as method validation reports, analytical sections of eCTD are highly desirable.

Preferred Attributes:

Good oral and written English communication skills. Good conceptual, analytical, problem solving, and organizational skills.

Positive “can do” attitude, and a sense of urgency to get things done. Can makes decisions to resolve moderately complex problems in standard situations.

Makes smaller level decisions within guidelines, policies & procedures.

Can work independently in ambiguous situations as part of a work team.

Prior working experience in a cross-cultural set-up as well as a GLP/GMP set up

Strong understanding of large molecules (fusion proteins, mAbs, ADCs)

Work experience with LIMS is highly desirable.

Work Location Assignment: Flexible


Work Location Assignment: Flexible

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs#LI-PFE

  • CarbyneTech - SAP PS Consultant - E2E Implementation

    2 months ago

    Chennai, India CarbyneTech India Pvt Ltd Full time

    Job Requirements : - Minimum 8 years of strong experience in SAP PS module- SAP PS Consultant must have all required Project System functional and Configuration knowledge in SAP ECC/S4 HANA system.- SAP PS Implementation Experience: End-to-end Implementation experience in different domains - Manufacture, Construction, EPC or any other Industry.- Good...

  • IT Support Associate Ii, IT Services

    4 weeks ago

    Chennai, India ADCI - Tamil Nadu Full time

    Bachelor’s degree or Diploma in any discipline. - Total 2+ years of experience in IT support domain includes asset management. - Hands on experience in Windows. - Should be capable to complete the task following the standard operating procedure. - Should have experience in understanding IT equipment’s, peripherals and IT Warehouse. - Should have...

  • CarbyneTech - SAP PS Consultant - E2E Implementation

    2 months ago

    Chennai, India CarbyneTech India Pvt Ltd Full time

    Job Requirements :- Minimum 8 years of strong experience in SAP PS module- SAP PS Consultant must have all required Project System functional and Configuration knowledge in SAP ECC/S4 HANA system.- SAP PS Implementation Experience: End-to-end Implementation experience in different domains - Manufacture, Construction, EPC or any other Industry.- Good...

  • Pls Associate-ii

    4 weeks ago

    Chennai, India Pfizer Full time

    Why Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate...

  • Associate, Control II

    5 days ago

    Chennai, India THE BANK OF NEW YORK MELLON CORPORATION Full time

    Associate, Control II Bring your ideas. Make history.  BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the “bank of banks” - %...

  • SAP PS Consultant

    1 month ago

    Chennai, India Fortune HR Services Full time

    Job Description :Experienced required : 5 - 10 yearsShifts : Japanese shift (5:30 AM to 2:30 PM )Mode of work : HybridLocation : Pune, Chennai, BengaluruMust have skills :- Must have all required Project System functional and Configuration knowledge in SAP ECC system.- Budgeting, Costs, and Reporting- SAP S4 Hana- Project structures should be cleared.- PEC-...

  • Associate, Control II

    5 days ago

    Chennai, India BNY Mellon Full time

    Associate, Control IIBring your ideas. Make history. BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the “bank of banks” - 97% of the...

  • Associate, Compliance

    5 days ago

    chennai, India THE BANK OF NEW YORK MELLON CORPORATION Full time

    Associate, Compliance & Control II Bring your ideas. Make history.  BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the “bank of...

  • Associate Ii Reg Cmc Strategy, Si Lcm

    4 weeks ago

    Chennai, India Pfizer Full time

    Functions as the Global Product Owner (GPO) or Support GPOs for Life Cycle Management (LCM), working with cross-functional teams to prepare regulatory submissions for US, Europe, Canada, Australia and ROW Countries. - Responsible for the preparation of Global Regulatory Strategy Documents (GRSD) and CTD Sections of post approval submissions. - Preparation of...

  • Associate, Fund/Client Accounting II

    3 days ago

    Chennai, India THE BANK OF NEW YORK MELLON CORPORATION Full time

    Associate, Fund/Client Accounting II Bring your ideas. Make history.  BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the “bank...

  • Associate II – Reg CMC Strategy, Vaccines

    2 weeks ago

    chennai, India Pfizer Full time

    Why Patients Need You  We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and...

  • Associate Ii

    1 month ago

    Chennai, Tamil Nadu, India Pfizer Full time

    Why Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate...

  • Associate II – Reg CMC Strategy, SI LCM

    1 month ago

    Chennai, India Pfizer Full time

    Responsibility: Functions as support for GRS-CMC to perform the following activities (under supervision) for Nitrosamine assessment:Step 1 Assessment for Nitrosamine riskStep 2 Confirmatory testing Responsible for effective review and providing timely feedback to the GRL/RRL/CRL on technical documents (on a need basis). Remediation Planning:...

  • Associate II – Reg CMC Strategy, SI LCM

    1 month ago

    chennai, India Pfizer Full time

    Responsibility: Functions as support for GRS-CMC to perform the following activities (under supervision) for Nitrosamine assessment:Step 1 Assessment for Nitrosamine riskStep 2 Confirmatory testing Responsible for effective review and providing timely feedback to the GRL/RRL/CRL on technical documents (on a need basis). Remediation Planning:...

  • SAP Hana

    1 month ago

    Chennai, India Industrial Support Services Full time

    **Should have experience in SAP Developer as minimum 5yrs.** - Should have experience in SAP Version SAP S4/Hana, SAP ECC - Need to have knowledge in Production Planning, Production Management, Quality Management, Project Systems. - Should have experience in handling Queries extensively to accommodate various PP/QM/PM/PS related requirements. - Unit...

  • SAP PS Consultant

    1 month ago

    Pune,Chennai,Bangalore, India Fortune HR Services Full time

    Job Description :Experienced required : 5 - 10 yearsShifts : Japanese shift (5:30 AM to 2:30 PM )Mode of work : HybridLocation : Pune, Chennai, BengaluruMust have skills :- Must have all required Project System functional and Configuration knowledge in SAP ECC system.- Budgeting, Costs, and Reporting- SAP S4 Hana- Project structures should be cleared.- PEC-...

  • SAP PS Consultant

    1 month ago

    Pune/Chennai/Bangalore, IN Fortune HR Services Full time

    Job Description :Experienced required : 5 - 10 yearsShifts : Japanese shift (5:30 AM to 2:30 PM )Mode of work : HybridLocation : Pune, Chennai, BengaluruMust have skills :- Must have all required Project System functional and Configuration knowledge in SAP ECC system.- Budgeting, Costs, and Reporting- SAP S4 Hana- Project structures should be cleared.- PEC-...

  • Associate, Data Management

    5 days ago

    Chennai, India THE BANK OF NEW YORK MELLON CORPORATION Full time

    Associate, Data Management & Quantitative Analysis II Bring your ideas. Make history.  BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known...

  • Associate Ii, Reg Cmc Strategy, Si Lcm

    1 month ago

    Chennai, India Pfizer Full time

    Why Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate...

  • Data Scientist Ii

    4 weeks ago

    Chennai, India Caterpillar Full time

    **Career Area**:Information Analytics**: JOB PURPOSE: Caterpillar uses quantitative methods such as business simulations, data mining, and advanced statistical techniques to solve problems. The Data Scientist II contributes to this mission by leveraging his or her quantitative analysis, data management, modeling and/or data visualization skills as an...